Effects of Zazen Meditation in Patients With Acute Myocardial Infarction - Randomized Clinical Trial
Recruiting now · Not applicable
Conditions studied: Heart Rate Variability, Acute Myocardial Infarction
In brief
Introduction: Coronary Artery Disease (CAD) remains the leading cause of death in Brazil, with literature indicating that in patients post-acute myocardial infarction, reduced Heart Rate Variability (HRV) has been established as a risk factor. One of the studied practices to aid in rehabilitation is meditation, believed to alter physiological aspects related to stress such as respiratory rate, oxygen consumption, carbon dioxide production, and systolic blood pressure, suggesting a better sympathetic-vagal balance. Objective: To assess the effects of Zazen meditation practice on heart rate variability in patients with recent acute and chronic myocardial infarction. Methodology: Randomized Clinical Trial. Chronic assessments will include: HRV with Polar H10 heart rate monitor, Quality of Life assessment with SF36 Quality of Life and Health questionnaire, Spiritual assessment with WHOQOL SR Spirituality, Religiosity, and Personal Beliefs questionnaire, Biochemical Parameters with ultra-sensitive PCR and cortisol, Ventricular Ejection Fraction (VEF), and 6-minute Walk Test (6MWT). Acute assessments will include: HRV with Polar H10 heart rate monitor, before and after a meditation session, in time and frequency domains. Sample size calculation was performed using Winpepi software version 11.43, with a power of 80% and significance level of 5%, determining a sample of 44 individuals. For intra-group differences analysis, ANOVA for repeated measures and/or its non-parametric counterpart, Friedman Test, will be used. For proportion analysis and comparison, Chi-square Test will be used. Expected Results: It is expected that the findings will contribute to a better understanding of the potential benefits that a meditation intervention may bring to patients who have experienced acute myocardial infarction.
Key facts
- Study ID
- NCT06562478
- Run by
- Hospital de Clinicas de Porto Alegre
- People needed
- 44
- Starts
- 2024-02-05
- Expected to finish
- 2026-07-31
- Last updated by the study team
- 2024-08-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Recent acute myocardial infarction
- Both sexes
- >18 years old
- Availability to attend the hospital at least twice a week during the study period
- Agree to the study and sign the Free and Informed Consent Form.
You may not qualify if…
- Unstable angina
- Extensive residual myocardial ischemia (at rest or on exertion)
- Inadequate blood pressure response during exercise
- Congestive heart failure class III or IV
- Severe lung disease
- Difficulty or inability to walk
- Pacemaker
- Participation in other clinical trials
Where it is running
- Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
Full record on ClinicalTrials.gov
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